Cycling Deep Brain Stimulation on Parkinson's Disease Gait

NCT04408573 | Unknown

• 1 other identifier: 67914017.6.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (\>130Hz) stimulation, 2) cycling high frequency (\>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change in the part II of the Unified Parkinson's disease rating scale

  The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.

  Baseline + after 2 weeks + after 4 weeks + after 6 weeks

• Change in the New Freezing of Gait Questionnaire

  The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.

  Baseline + after 2 weeks + after 4 weeks + after 6 weeks

Secondary Outcomes (4)

• Change in Falls Efficacy Scale

  Baseline + after 2 weeks + after 4 weeks + after 6 weeks

• Change in The Parkinson's Disease Questionnaire (PDQ-39)

  Baseline + after 2 weeks + after 4 weeks + after 6 weeks

• Change in Activities-Specific Balance Confidence Scale (ABC scale)

  Baseline + after 2 weeks + after 4 weeks + after 6 weeks

• Number of falls

  Baseline + after 2 weeks + after 4 weeks + after 6 weeks

Study Arms (4)

Regular Continuous High Frequency

NO INTERVENTION

Patient remains 2 weeks in the currently chosen stimulation protocol.

Cycling High Frequency

EXPERIMENTAL

Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF

Other: Cycling deep brain stimulation

Continuous Low Frequency

EXPERIMENTAL

Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.

Other: Cycling deep brain stimulation

Cycling Low Frequency

EXPERIMENTAL

Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.

Other: Cycling deep brain stimulation

Interventions

Cycling deep brain stimulation OTHER

Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF

Continuous Low Frequency; Cycling High Frequency; Cycling Low Frequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease
• Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
• Hoehn \& Yahr stage between 2-4 during off-medication
• Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
• Willingness to comply with all study procedures

You may not qualify if:

• Active moderate/severe psychiatric condition
• Active infection or other uncontrolled moderate/grave comorbidities
• Treatment with experimental drug
• Pregnancy or breast-feeding

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Rubens G Cury, MD, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubens G Cury, MD, PhD

CONTACT

55 11 26617877; rubens_cury@usp.br

Carina C França, MD

CONTACT

55 11 26617877; carina.fr@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 weeks of regular continuous high frequency (\>130Hz) stimulation, 2 weeks of cycling high frequency (\>130Hz) stimulation (40sec on, 2sec off), 2 weeks of low-frequency (80Hz) continuous stimulation and 2 weeks of cycling low frequency (80Hz) stimulation (40sec on, 2sec off)

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: June 19, 2020
• Primary Completion: May 29, 2021
• Study Completion: December 29, 2021
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available indefinitely upon reasonable request from other authors
• Access Criteria: Investigator Rubens Cury will analyse request and decide upon reasonability

Locations

BR (1)